Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.
Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.
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DOI：
10.1097/cce.0000000000000738
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发表时间：
2022-07
影响因子：
--
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中科院分区：
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评估已发表的重症监护随机对照试验的实用性，这些试验自称为实用性，使用经过验证的工具。医学文献分析和检索在线数据库和 PubMed 界面，从开始到 2021 年 11 月 1 日。我们对随机对照试验进行了系统检索，评估了对危重成人的干预措施，这些试验在标题或摘要中自我认为是务实的。评审员独立进行研究选择和数据提取，一式两份；分歧以协商一致方式解决。实用主义由训练有素的审稿人使用实用-解释连续体指标摘要 2 (PRECIS-2) 进行独立评估，该指标摘要 2 (PRECIS-2) 是一种经过验证的工具，旨在表示试验在实用到解释连续体上的解释性/实用性。试验在 9 个领域进行了 5 分连续评分（从 1 = 非常解释性到 5 = 非常务实）。差异大于2分的，通过协商一致讨论判定。检索结果为 284 项研究； 56 人符合资格标准。其中 41 项试验至少在一个需要达成共识的领域存在差异，最常见的是资格和随访领域。 12 项研究 (21.4%) 被评为“整体务实”，定义为在五个领域得分大于 4，前提是其余领域得分为 3。自我认定的实用性研究的总体 PRECIS-2 得分从 1995 年到 2021 年有所上升，表明实用主义随着时间的推移而增强。务实试验更有可能放弃知情同意（p = 0.05）。自我认定的实用性试验的数量和实用主义有所增加，特别是在过去十年中。然而，在标题或摘要中使用实用术语的这些试验中，只有不到四分之一被回顾性地评为实用。我们的结果支持这样的概念：试验是根据实用性到解释性的范围设计的。需要在重症监护试验的设计和报告方面取得进展，以确保其现实世界的适用性。
To assess the pragmatism of published critical care randomized controlled trials self-described as pragmatic using a validated tool. Medical Literature Analysis and Retrieval Online database and PubMed interface from inception to November 1, 2021. We performed a systematic search of randomized controlled trials evaluating interventions for critically ill adults that self-identified as pragmatic in title or abstract. Reviewers independently performed study selection and data extraction in duplicate; discrepancies were resolved by consensus. Pragmatism was assessed independently in duplicate by trained reviewers using the Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2), a validated tool designed to represent how explanatory/pragmatic a trial is on the pragmatic to explanatory continuum. Trials were scored in nine domains on a 5-point continuum (from 1 = very explanatory to 5 = very pragmatic). Discrepancies of greater than 2 points were adjudicated by consensus discussion. The search resulted in 284 studies; 56 met eligibility criteria. Forty-one of the trials had a discrepancy in at least one domain that required consensus discussion, most commonly in domains of eligibility and follow-up. Twelve studies (21.4%) were scored as “overall pragmatic,” defined as score of greater than 4 in five domains provided the scores in the remaining domains were three. The overall PRECIS-2 score of self-identified pragmatic studies increased from 1995 to 2021 suggesting increasing pragmatism over time. Pragmatic trials were more likely to have a waiver of informed consent (p = 0.05). The number and pragmatism of self-identified pragmatic trials have increased, particularly in the past decade. However, less than one-quarter of these trials that use the term pragmatic in title or abstract were retrospectively rated as pragmatic. Our results support the concept that trials are designed on a spectrum of pragmatic to explanatory. Advances in the design and reporting of critical care trials are needed to ensure their real-world applicability.
影响因子：
2.8
作者：
Glasgow RE;Gurfinkel D;Waxmonsky J;Rementer J;Ritchie ND;Dailey-Vail J;Hosokawa P;Dickinson LM;Kwan BM
通讯作者：
Kwan BM